Medical Reviewer

Medical Reviewer

Tata Consultancy Services | Indore, MP, IN

Posted 13 days ago

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Description

Role - Medical Reviewer

Experience - 1 years to 4 years

Location - Indore

Qualification - MBBS, MD


Desired Competency:

1. Accountable for the medical review of relevant clinical and spontaneous cases (including literature articles), medical assessment (including listedness and causality) and overall cohesiveness of individual case safety reports for a particular product or group of products on a national, regional, or global basis in line with regulatory and SOP requirements.

2. Accountable for the final medical review of ICSRs including decisions on potential SUSARs in a timely fashion and ensuring that all necessary queries have been addressed.

3. Perform tasks such as writing Analysis of Similar Events, safety letters, communication with the appropriate Safety Science Leader and where appropriate with the Clinical Science Group.

4. Responsible for generating, sending and tracking data queries, together with other PDSO staff, to Affiliates, SAE responsible and regional centers.

5. Developing and maintaining knowledge of the appropriate disease biology areas for marketed drugs and drugs in development for which the Safety Operations Physician is responsible.